Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

Key facts

Study ID

NCT01397786

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

1044

Starts

2011-09-01

Expected to finish

2016-01-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
• Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
• Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
• Other protocol specific inclusion criteria may apply.

You may not qualify if…

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• Subjects with a current DSM-IV-TR Axis I diagnosis of:
• Schizoaffective disorder
• MDD
• Bipolar disorder
• Delirium, dementia, amnestic or other cognitive disorder
• Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
• Subjects presenting with a first episode of schizophrenia
• Other protocol specific exclusion criteria may apply.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Springdale, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Cerritos, California, United States
• Study site — Escondido, California, United States
• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — Long Beach, California, United States
• Study site — National City, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — Pico Rivera, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Springs, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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